125742 45 S211 M5 c4591001 1039 10391285

Document text

Page 1 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version01 DEC 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494949
Page 2 of 316
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/18/2020
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494950
Page 3 of 316
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [10391285]
2.Birth Date: /2007
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0494951
Page 4 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494952
Page 5 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494953
Page 6 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathDec/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494954
Page 7 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[amoxicillin allergy]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[premenarche]
Start Date: /2007
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[vegetarian]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0494955
Page 8 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494956
Page 9 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Dec/18/2020
2.Weight: [40.8]
3.Unit: kg
4.Height: [156.1]
5.Unit: cm
6.Body Mass Index: [16.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494957
Page 10 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/18/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494958
Page 11 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Dec/18/2020
2.Randomization Number: [23275]
3.Randomization Group: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494959
Page 12 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS6HKS]
5.bSample ID [BRJBLY]
5.cSample ID [BRJBLZ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494960
Page 13 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJB6G]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494961
Page 14 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/18/2020 09:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494962
Page 15 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494963
Page 16 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494964
Page 17 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494965
Page 18 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494966
Page 19 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494967
Page 20 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/8/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494968
Page 21 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494969
Page 22 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJBB9]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494970
Page 23 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jan/8/2021 08:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494971
Page 24 of 316
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494972
Page 25 of 316
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494973
Page 26 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494974
Page 27 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494975
Page 28 of 316
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGCCB]
5.bSample ID [BRGCCC]
5.cSample ID [BS6HG5]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494976
Page 29 of 316
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Applicable
//Comments
2.Erroneous Visit ERRONEOUS VISIT
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494977
Page 30 of 316
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected? Not Applicable Comments
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGCKT ]
5.bSample ID [BLBDNB ]
5.cSample ID [BS6HTX ]
5.dSample ID [BRMFT9 ]
5.eSample ID [BRGCKV ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494978
Page 31 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494979
Page 32 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494980
Page 33 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494981
Page 34 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494982
Page 35 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494983
Page 36 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494984
Page 37 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494985
Page 38 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494986
Page 39 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494987
Page 40 of 316
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494988
Page 41 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jul/26/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/26/2021
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494989
Page 42 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jul/26/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494990
Page 43 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jul/26/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Jul/26/2021
Contact Outcome:
VISIT NOT REQUIRED, DATA ENTRY ERROR IN
E-DIARY
3.Comments: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494991
Page 44 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494992
Page 45 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494993
Page 46 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494994
Page 47 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494995
Page 48 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494996
Page 49 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494997
Page 50 of 316
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/26/2021
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494998
Page 51 of 316
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/26/2021
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494999
Page 52 of 316
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/26/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLBDNB]
5.bSample ID [BRGCKT]
5.cSample ID [BRGCKV]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495000
Page 53 of 316
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/26/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMFT9]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495001
Page 54 of 316
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Feb/5/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495002
Page 55 of 316
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Apr/09/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/9/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495003
Page 56 of 316
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Apr/09/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA00171]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495004
Page 57 of 316
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Apr/22/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/22/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495005
Page 58 of 316
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Apr/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA01236]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495006
Page 59 of 316
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on May/06/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/6/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK6
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495007
Page 60 of 316
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on May/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/6/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA00189]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495008
Page 61 of 316
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/12/2021
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495009
Page 62 of 316
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495010
Page 63 of 316
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495011
Page 64 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  fatigue  May/14/202
1 18:00 NO
End Date Time:
May/15/2021 18:00
 Repeating
Pages
 2.ADVERSE
EVENT 2  nausea  May/14/202
1 18:00 NO
End Date Time:
May/15/2021 18:00
 Repeating
Pages
 3.ADVERSE
EVENT 3  injection site
pain May/15/202
1 08:00 NO
End Date Time:
May/15/2021 UNK
:UNK
 Repeating
Pages
 4.ADVERSE
EVENT 4  fever  Jun/4/2021
14:00 NO
End Date Time:
Jun/5/2021 UNK:U
NK
 Repeating
Pages
 5.ADVERSE
EVENT 5  nausea  Jun/4/2021
14:00 NO
End Date Time:
Jun/5/2021 UNK:U
NK
 Repeating
Pages
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495012
Page 65 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 6.ADVERSE
EVENT 6  muscle aches  Jun/4/2021
14:00 NO
End Date Time:
Jun/5/2021 UNK:U
NK
 Repeating
Pages
 7.ADVERSE
EVENT 7  Generalized
Arthralgia Jun/4/2021
14:00 NO
End Date Time:
Jun/5/2021 UNK:U
NK
 Repeating
Pages
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495013
Page 66 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[fatigue]
4.Start Date Time: May/14/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
May/15/2021 18:00
6.Toxicity Grade: 1
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495014
Page 67 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495015
Page 68 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495016
Page 69 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[nausea]
4.Start Date Time: May/14/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
May/15/2021 18:00
6.Toxicity Grade: 1
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495017
Page 70 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495018
Page 71 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495019
Page 72 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[injection site pain]
4.Start Date Time: May/15/2021 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
May/15/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495020
Page 73 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495021
Page 74 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495022
Page 75 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[fever]
4.Start Date Time: Jun/4/2021 14:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/5/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495023
Page 76 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495024
Page 77 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495025
Page 78 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[nausea]
4.Start Date Time: Jun/4/2021 14:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/5/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495026
Page 79 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495027
Page 80 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495028
Page 81 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[muscle aches]
4.Start Date Time: Jun/4/2021 14:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/5/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495029
Page 82 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495030
Page 83 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495031
Page 84 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Generalized Arthralgia]
4.Start Date Time: Jun/4/2021 14:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/5/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495032
Page 85 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495033
Page 86 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495034
Page 87 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495035
Page 88 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495036
Page 89 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495037
Page 90 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495038
Page 91 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495039
Page 92 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495040
Page 93 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495041
Page 94 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495042
Page 95 of 316
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495043
Page 96 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495044
Page 97 of 316
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/12/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495045
Page 98 of 316
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495046
Page 99 of 316
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495047
Page 100 of 316
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/14/2021
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495048
Page 101 of 316
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
May/14/2021
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495049
Page 102 of 316
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495050
Page 103 of 316
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :May/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495051
Page 104 of 316
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: May/14/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495052
Page 105 of 316
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
May/14/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDP7D]
5.bSample ID [BRDP7F]
5.cSample ID [BLBDDB]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495053
Page 106 of 316
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
May/14/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMFWG]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495054
Page 107 of 316
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: May/14/2021 08:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495055
Page 108 of 316
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/4/2021
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495056
Page 109 of 316
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jun/4/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495057
Page 110 of 316
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jun/4/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMFXW]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495058
Page 111 of 316
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jun/4/2021 08:16
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495059
Page 112 of 316
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/12/2021
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495060
Page 113 of 316
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Jul/12/2021
3.Comments: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495061
Page 114 of 316
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495062
Page 115 of 316
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495063
Page 116 of 316
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495064
Page 117 of 316
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495065
Page 118 of 316
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jul/12/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495066
Page 119 of 316
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Feb/5/2021
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495067
Page 120 of 316
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495068
Page 121 of 316
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Gretchen
Crook Approved Sep-01-2021 10:02:02 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GretchenCrook, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495069
Page 122 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormDec-18-2020 13:36:49 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495070
Page 123 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495071
Page 124 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495072
Page 125 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495073
Page 126 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495074
Page 127 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495075
Page 128 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495076
Page 129 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495077
Page 130 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495078
Page 131 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-08-2021 15:05:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495079
Page 132 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Apr-22-2021 09:18:59 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495080
Page 133 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Mar-30-2021 10:12:35 (UTC-06:00)
Central Time (US & Canada)Form level comment is not a radial
option, and only a comment box
populates.
Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495081
Page 134 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Mar-30-2021 10:13:01 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495082
Page 135 of 316
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-14-2021 10:04:38 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495083
Page 136 of 316
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Gretchen
Crook Approved Sep-01-2021 10:02:02 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GretchenCrook, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-26-2021 10:21:01 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gretchen
Crook Approved Mar-10-2021 14:46:57 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495084
Page 137 of 316
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, GretchenCrook, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495085
Page 138 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Dec-18-2020
13:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
01 DEC 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Dec-18-2020
13:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495086
Page 139 of 316
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-18-2020
13:33:45
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Dec/18/2020Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495087
Page 140 of 316
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-18-2020
13:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
10391285Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Dec-18-2020
13:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
/2007Enrollment Entry
3. Sex:
Date Location User Value Reason
Dec-18-2020
13:34:08
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Dec-18-2020
13:34:08ACV0PF
EINFP60Data Entry:
NOT HISPANIC OR LATINInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495088
Page 141 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US & Canada)00  O(A) OR OF SPANISH ORI
GIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Dec-18-2020
13:34:08
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
6. Racial Designation:
Date Location User Value Reason
Jan-21-2021
23:58:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
Jan-21-2021
20:39:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 2: Closed Auto closed by
Validation Check:
VC_DM001_09
Jan-21-2021
13:34:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Answere
dChanged Information
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2022-5812-0495089
Page 142 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-21-2021
13:34:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answere
dChanged Information
Jan-21-2021
13:34:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry: Changed Information
Jan-21-2021
12:41:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 2: Opened DMW6938339;Racial
Designation is
updated, however
Race is not ASIAN.
Please review and
update appropriately
or clarify.
Jan-21-2021
11:32:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 1: Opened DMW6938339;Racial
Designation is
updated, however
Race is not ASIAN.
Please review and
update appropriately
or clarify.
Dec-18-2020
13:34:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
OTHERInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0495090
Page 143 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020
13:36:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/18/2020Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495091
Page 144 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Dec-18-2020
13:38:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-18-2020
13:38:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Dec-18-2020
13:38:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495092
Page 145 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Dec-18-2020
13:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:amoxicillin
allergy
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Dec-18-2020
13:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-18-2020
13:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
amoxicillin allergyInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495093
Page 146 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.a Start Date:
Date Location User Value Reason
Dec-18-2020
13:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Dec-18-2020
13:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Dec-18-2020
13:49:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:premenarc
he
Start Date: 2
007
Ongoing: YESInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495094
Page 147 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Dec-18-2020
13:49:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-18-2020
13:49:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
premenarcheInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-13-2021
10:29:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Dec-30-2020
11:03:31
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data
per query
Dec-23-2020 ACV0PF Query 1: Opened Please update
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495095
Page 148 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
14:30:24
(UTC-06:00) Central
Time (US &
Canada)EINFP60
00 source
documents to
include start
date as
appropriate.
Dec-18-2020
13:49:49
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
/2007Initial Entry
1.b Ongoing:
Date Location User Value Reason
Dec-18-2020
13:49:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Dec-18-2020
13:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical Histor
y Term:vegetarian
Start Date: UNK/UNK
/2019
Ongoing: YESInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495096
Page 149 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.c Line/MH Number:
Date Location User Value Reason
Dec-18-2020
13:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-18-2020
13:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
vegetarianInitial Entry
1.c Start Date:
Date Location User Value Reason
Dec-18-2020
13:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Dec-18-2020
13:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495097
Page 150 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Dec-18-2020
13:41:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495098
Page 151 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
40.8Initial Entry
3. Unit:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Dec-18-2020 ACV0PF Data Entry: Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495099
Page 152 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13:44:51
(UTC-06:00) Central
Time (US & Canada)EINFP60
00 156.1
5. Unit:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
16.7Initial Entry
7.a
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 36.7
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495100
Page 153 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.a Record Identifier:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Dec-18-2020
13:44:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495101
Page 154 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-18-2020
13:44:21
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-18-2020
13:44:21
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-18-2020
13:44:21
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-18-2020 ACV0PF auto calc Data Entry: Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495102
Page 155 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13:44:21
(UTC-06:00) Central
Time (US & Canada)EINFP60
00 (autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Dec-18-2020
13:44:21
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Dec-18-2020
13:44:21
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-18-2020
13:44:21
(UTC-06:00) CentralACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
113Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495103
Page 156 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
6.a Test:
Date Location User Value Reason
Dec-18-2020
13:44:21
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Dec-18-2020
13:44:21
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOT DONEInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495104
Page 157 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Dec-18-2020
13:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Dec-18-2020
13:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
23275Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495105
Page 158 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020
13:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020
13:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020
17:02:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-18-2020
13:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495106
Page 159 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Dec-18-2020
13:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020
17:02:11
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BS6HKSInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020
17:02:11
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BS6HKSInitial Entry
5.b
Date Location User Value Reason
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495107
Page 160 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-18-2020
17:02:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRJBLYInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020
17:02:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRJBLYInitial Entry
5.c
Date Location User Value Reason
Dec-18-2020
17:02:23
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRJBLZInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495108
Page 161 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
Dec-18-2020
17:02:23
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRJBLZInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495109
Page 162 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020
13:43:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020
13:43:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020
17:22:20
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-18-2020
13:43:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495110
Page 163 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Dec-18-2020
13:43:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020
17:22:20
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRJB6GInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020
17:22:20
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRJB6GInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495111
Page 164 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-18-2020
13:45:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-18-2020
13:45:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-18-2020
13:45:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-18-2020
13:45:38ACV0PF
EINFP60Data Entry:
Dec/18/2020 09:59Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495112
Page 165 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US & Canada)00 
5. Anatomical Location:
Date Location User Value Reason
Dec-18-2020
13:45:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-18-2020
13:45:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-18-2020
13:45:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-18-2020
13:45:38ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIEInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495113
Page 166 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US & Canada)00  D OBSERVATION PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-13-2021
10:30:08
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Dec-30-2020
11:05:28
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data
per query
Dec-23-2020
14:02:03
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened Please reconcile
source
documents with
beginning of
surveillance
time and update
as appropriate.
Dec-18-2020
13:45:38
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495114
Page 167 of 316
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Dec-18-2020
13:41:34
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED F
OR THIS SUBJECTInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495115
Page 168 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021
10:30:36
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-12-2021
12:20:16
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data
per query
Jan-12-2021
10:21:24
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened Please provide
source
documents in
Florence.
Jan-08-2021
15:05:12
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/8/2021Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495116
Page 169 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
E
R
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-08-2021
15:07:30ACV0PF
EINFP60Data Entry:
FEVERInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495117
Page 170 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US & Canada)00 
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495118
Page 171 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495119
Page 172 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:N
OInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495120
Page 173 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495121
Page 174 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495122
Page 175 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAINInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495123
Page 176 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.g Symptom:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENEDInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495124
Page 177 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NO
2.h Symptom:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-08-2021 15:07:30
(UTC-06:00) CentralACV0PF
EINFP60auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495125
Page 178 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada) 00 
4. Injection Site Body Side:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495126
Page 179 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subje
ct Diary was comple
ted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495127
Page 180 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present
on the last day the
Subject Diary was
completed?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495128
Page 181 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
15:07:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495129
Page 182 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-08-2021
15:05:29
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/8/2021Initial Entry
2.a
Date Location User Value Reason
Jan-08-2021
15:05:29
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 36.6
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-08-2021
15:05:29
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
2.a Temperature:
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495130
Page 183 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-08-2021
15:05:29
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-08-2021
15:05:29
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Jan-08-2021
15:05:29
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495131
Page 184 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-08-2021 ACV0PF Data Entry: Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495132
Page 185 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
15:05:52
(UTC-06:00) Central
Time (US & Canada)EINFP60
00 Not Applicable
5. Specimen Type:
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sponsor-Define
d Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495133
Page 186 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
6.a Test:
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-08-2021
15:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495134
Page 187 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 15:07:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 15:07:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-08-2021
16:19:03
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-08-2021
15:07:40
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495135
Page 188 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Jan-08-2021
15:07:40
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/8/2021Initial Entry
5.a
Date Location User Value Reason
Jan-08-2021
16:19:03
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRJBB9Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-08-2021
16:19:03
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRJBB9Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495136
Page 189 of 316
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-08-2021
15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-08-2021 15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-08-2021 15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-08-2021
15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/8/2021 08:51Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495137
Page 190 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Anatomical Location:
Date Location User Value Reason
Jan-08-2021 15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-08-2021
15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-08-2021 15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-08-2021 15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495138
Page 191 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-08-2021
15:06:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495139
Page 192 of 316
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021
10:26:53
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/5/2021Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495140
Page 193 of 316
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
ER
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495141
Page 194 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495142
Page 195 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495143
Page 196 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495144
Page 197 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495145
Page 198 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495146
Page 199 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAINInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495147
Page 200 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NO
2.g Symptom:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENEDInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495148
Page 201 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NO
2.h Symptom:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Feb-05-2021
10:27:19ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495149
Page 202 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US & Canada)00 
4. Injection Site Body Side:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495150
Page 203 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495151
Page 204 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reac
tion::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495152
Page 205 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Injection Site Reaction:
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
10:27:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495153
Page 206 of 316
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-05-2021
10:27:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-05-2021
10:27:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021
14:09:35
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-05-2021
10:27:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495154
Page 207 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-05-2021
10:27:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/5/2021Initial Entry
5.a
Date Location User Value Reason
Feb-05-2021
14:10:24
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRGCCBTranscription
Error
Feb-05-2021
14:09:35
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: brgccbInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-05-2021
14:10:24
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-05-2021
14:10:24ACV0PF
EINFP60Data Entry:
BRGCCBTranscription
Error
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495155
Page 208 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US & Canada)00 
Feb-05-2021
14:09:35
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Barcode contains
lower case
letters which is
not the correct
format. Please
review and
correct as
appropriate.
Feb-05-2021
14:09:35
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
brgccbInitial Entry
5.b
Date Location User Value Reason
Feb-05-2021
14:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRGCCCTranscription
Error
Feb-05-2021
14:10:43
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: brgcccInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495156
Page 209 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Feb-05-2021
14:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-05-2021
14:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRGCCCTranscription
Error
Feb-05-2021
14:10:43
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Barcode contains
lower case
letters which is
not the correct
format. Please
review and
correct as
appropriate.
Feb-05-2021
14:10:43
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
brgcccInitial Entry
5.c
Date Location User Value Reason
Feb-05-2021
14:18:41
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
Sample ID: BS6HG5Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495157
Page 210 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
5.c Sample ID
Date Location User Value Reason
Feb-05-2021
14:18:41
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BS6HG5Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495158
Page 211 of 316
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Apr-22-2021
09:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-26-2021
13:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ERRONEOUS VISITInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0495159
Page 212 of 316
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-30-2021
10:11:15
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry: Changed
Information
Mar-26-2021
13:28:54
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-30-2021
10:11:15
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry: Changed
Information
Mar-26-2021
13:28:54
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495160
Page 213 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-31-2021
07:21:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Closed Response
satisfies query
Mar-30-2021
10:12:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
Mar-30-2021
10:11:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Answered Answer Auto
Query
Mar-30-2021
10:11:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry: Changed
Information
Mar-30-2021
00:25:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Reissued:Opened DM1: Form
level comment
is still missing
on this form.
Kindly consider
to erase the data
from this form
and then add
form level
comment by
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495161
Page 214 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
selecting Not
Done or Not
Applicable
option on this
form or else
clarify.
Mar-29-2021
07:14:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Answered N/A
Mar-29-2021
03:05:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Reissued:Opened DM: If entered
in error, please
consider adding
form level 'Not
applicable'
comment on this
form. Thank
you.
Mar-26-2021
13:53:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Answered The samples
were inputted in
the wrong visit.
It was supposed
to be in V201
and not V4
Mar-26-2021
13:44:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 7: Closed Close Auto
Query
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495162
Page 215 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-26-2021
13:44:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 7: Opened Response to
"Sample
Collected?" is
No, but
Barcodes are
present on the
page.
Mar-26-2021
13:44:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 6: Closed Close Auto
Query
Mar-26-2021
13:43:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 6: Opened Response to
"Sample
Collected?" is
No, but
Barcodes are
present on the
page.
Mar-26-2021
13:43:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 5: Closed Close Auto
Query
Mar-26-2021
13:43:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 5: Opened Response to
"Sample
Collected?" is
No, but
Barcodes are
present on the
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495163
Page 216 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
page.
Mar-26-2021
13:43:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 4: Closed Close Auto
Query
Mar-26-2021
13:43:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 4: Opened Response to
"Sample
Collected?" is
No, but
Barcodes are
present on the
page.
Mar-26-2021
13:43:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 3: Closed Close Auto
Query
Mar-26-2021
13:42:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 3: Opened Response to
"Sample
Collected?" is
No, but
Barcodes are
present on the
page.
Mar-26-2021
13:42:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Opened 'Sample
Collected?' is
marked as No
and 'If no
sample was
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495164
Page 217 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
collected or
sample was not
collected
according to
protocol, please
provide reason'
is missing.
Please review
and update as
appropriate.
Mar-26-2021
13:42:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOTranscription
Error
Mar-26-2021
13:29:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-26-2021
13:28:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Mar-26-2021
13:28:54ACV0PF
EINFP60Data Entry:
YESInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495165
Page 218 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00)
Central Time (US &
Canada)00  Date of Collection:
Mar/26/2021
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Mar-30-2021
10:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Mar-26-2021
13:43:24
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRGCKTTranscription
Error
(DELETED)
Mar-26-2021
13:29:36
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRGCKTInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0495166
Page 219 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-26-2021
13:43:24
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRGCKTTranscription
Error
(DELETED)
Mar-26-2021
13:29:36
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRGCKTInitial Entry
5.b
Date Location User Value Reason
Mar-26-2021
13:43:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BLBDNBTranscription
Error
(DELETED)
Mar-26-2021
13:29:52
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BLBDNBInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0495167
Page 220 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Mar-26-2021
13:43:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BLBDNBTranscription
Error
(DELETED)
Mar-26-2021
13:29:52
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BLBDNBInitial Entry
5.c
Date Location User Value Reason
Mar-26-2021
13:43:52
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BS6HTXTranscription
Error
(DELETED)
Mar-26-2021
13:30:07
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BS6HTXInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0495168
Page 221 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
Mar-26-2021
13:43:52
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BS6HTXTranscription
Error
(DELETED)
Mar-26-2021
13:30:07
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BS6HTXInitial Entry
5.d
Date Location User Value Reason
Mar-26-2021
13:44:05
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRMFT9Transcription
Error
(DELETED)
Mar-26-2021
13:30:27
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRMFT9Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0495169
Page 222 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.d Sample ID
Date Location User Value Reason
Mar-26-2021
13:44:05
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRMFT9Transcription
Error
(DELETED)
Mar-26-2021
13:30:27
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRMFT9Initial Entry
5.e
Date Location User Value Reason
Mar-26-2021
13:44:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRGCKVTranscription
Error
(DELETED)
Mar-26-2021
13:34:13
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRGCKVInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0495170
Page 223 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.e Sample ID
Date Location User Value Reason
Mar-26-2021
13:44:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRGCKVTranscription
Error
(DELETED)
Mar-26-2021
13:34:13
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRGCKVInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0495171
Page 224 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jul/26/2021Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-26-2021
14:13:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jul/26/2021Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495172
Page 225 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jul/26/2021Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Assessments
Date Location User Value Reason
Jul-26-2021
14:14:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jul-26-2021
14:13:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Jul-26-2021
14:13:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495173
Page 226 of 316
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jul/26/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Jul-26-2021 14:14:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Jul-26-2021
14:14:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Contact:
Jul/26/2021
Contact Outcome:
VISIT NOT REQUIRE
D, DATA ENTRY ER
ROR IN E-DIARYInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495174
Page 227 of 316
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-26-2021
10:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Mar/26/2021Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495175
Page 228 of 316
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-26-2021
10:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Mar/26/2021Initial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495176
Page 229 of 316
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-26-2021
10:21:34
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-26-2021
10:21:34
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-26-2021
13:45:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-26-2021
10:21:34
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495177
Page 230 of 316
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson
Parke
Subject No: 10391285 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Mar-26-2021
10:21:34
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Mar/26/2021Initial Entry
5.a
Date Location User Value Reason
Mar-26-2021
13:45:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BLBDNBInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-26-2021
13:45:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BLBDNBInitial Entry
5.b
Date Location User Value Reason
Mar-26-2021
13:45:35
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
Sample ID: BRGCKTInitial Entry
090177e19891a043\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FD
…[truncated]